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Elaprase

idursulfase
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease

Elaprase (idursulfase) is a medication that can be used to improve walking ability and lower spleen size in people with Hunter syndrome. It's only given once weekly as an intravenous (IV) infusion by a healthcare provider. But infusions typically take 1 to 3 hours and can put you at risk for serious allergic reactions. It's only available as a brand name medication, so it can be expensive.

Reviewed by:
reviewer
Sarah Lobello Pearson, PharmD
reviewer
Connie Zheng, PharmD
Last reviewed on March 15, 2022
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsCostPricesMedicare
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What is Elaprase (idursulfase)?

What is Elaprase (idursulfase) used for?

  • Improve walking ability in people ages 5 years and older with Hunter syndrome

  • Lower spleen size in people ages 16 months to 5 years old with Hunter syndrome

How Elaprase (idursulfase) works

Elaprase (idursulfase) is an enzyme replacement therapy (ERT), which means that it replaces an enzyme (protein) in your body. If you have Hunter syndrome, you either don't have any or don’t have enough of an enzyme that breaks down certain sugars in your body. These sugars build up in your body over time and can cause symptoms such as stiff joints, lung problems, and heart problems. Elaprase (idursulfase) replaces the missing enzyme and breaks down the sugars, providing relief from some symptoms of Hunter syndrome.

Drug Facts

Common BrandsElaprase
Drug ClassEnzyme replacement therapy
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Elaprase (idursulfase)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Headache (28%)
  • Itching (25%)
  • Rash (19%)
  • Hives (16%)
  • Flushing (16%)

Other Side Effects

  • Muscle pain
  • Fatigue
  • Diarrhea
  • Cough
  • Chills
  • Fast heart rate

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious allergic reactions: swelling of the face, throat or tongue, wheezing, hives, rash, flushing, vomiting
  • Worsening of heart or lung problems: fast heartbeat, difficulty breathing, nausea, chest pain, skin turning blue

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bone or muscle pain

chest pain

chills

cough

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

fever

headache

hives or welts

itching

rash

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

sneezing

sore throat

tightness in the chest

unusual tiredness or weakness

Less common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

Incidence not known

Difficulty with swallowing

dilated neck veins

extreme fatigue

heart stops

irregular breathing

no breathing

no pulse or blood pressure

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unconscious

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in hearing

diarrhea

ear drainage

earache or pain in the ear

Less common

Nausea

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Elaprase (idursulfase)

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Pros

Taken once a week

The only FDA-approved ERT for people with Hunter syndrome

Can be used in children as young as 5 years old to help them walk longer distances

If it's well-tolerated, you might be able to get at-home infusions and shortened infusion times

thumbs-down

Cons

Can cause a life-threatening allergic reaction

Can worsen lung and heart problems

Must be given by a healthcare provider, usually at a treatment center

Only available as a brand medication, so it can be expensive

pharmacist-tips

Pharmacist tips for Elaprase (idursulfase)

pharmacist

  • Mark your calendar to help you remember your weekly infusion appointments so you don't miss any doses of Elaprase (idursulfase).

    • Life-threatening allergic reactions can occur up to 24 hours after treatment with Elaprase (idursulfase). Tell your provider right away if any signs of an allergic reaction happen during or after your infusion. Those signs can include trouble breathing, dizziness, rash, hives, itching, flushing, fever and/or headache.

      • Let your provider know if you’ve had an allergic reaction to Elaprase (idursulfase). You might have to take medications such as, antihistamines, corticosteroids, or rescue inhalers to help prevent or ease an allergic reaction before or during your next treatment. Or, you might need to get the infusion over a longer period of time. Your provider can decide whether or not it's safe to continue with treatments after a serious allergic reaction.

        • Elaprase (idursulfase) probably won't improve your child's ability to walk right away (for children 5 years and older). It can take some time, maybe even up to a year, for you to see noticeable improvements. Talk with your child's provider if you have questions about whether or not this medication is working.

          • If you or your child takes Elaprase (idursulfase), talk to your provider about participating in the Hunter Outcome Survey. This program helps track how Hunter syndrome progresses, and the long-term effects Elaprase (idursulfase) might have on the people who take it.

            faqs

            Frequently asked questions about Elaprase (idursulfase)

            How is Elaprase (idursulfase) given?
            The dose of Elaprase (idursulfase) that you'll get depends on your weight, so it's important to be weighed regularly by your healthcare provider to make sure you're still on the right dose. The medication must be given as an IV infusion by a healthcare provider once a week. The infusion is usually given at a treatment center and can take up to 3 hours. You might have to have a longer infusion time if you experienced any side effects from the medication in the past. If you tolerate it well, sometimes the infusion time can be gradually shortened to 1 hour.
            Should I still get a dose of Elaprase (idursulfase) if I'm not feeling well?
            You should always let your healthcare provider know if you're not feeling well before an infusion. If you have a breathing problem, fever, or a lung infection, you could be at higher risk of making these problems worse if you have an allergic reaction to Elaprase (idursulfase).
            Can I get an Elaprase (idursulfase) infusion at home?
            If you tolerate the infusions at the treatment center well over several months, your healthcare provider might be able to set up a home infusion of Elaprase (idursulfase). The medication would still have to be given by a healthcare provider, and it might require a special approval from your insurance. It's important that you continue to be aware of any signs of an allergic reaction (e.g. rash, itching, trouble breathing) when getting Elaprase (idursulfase) infusions at home and get medical help if needed.
            Is Elaprase (idursulfase) a specialty medication?
            Yes, Elaprase (idursulfase) can be considered a specialty medication. There's no clear, set definition for what's a specialty medication, but typically they're medications that are expensive, need to be stored or handled in special ways, and given by healthcare providers. You might need to get Elaprase (idursulfase) at a specialty pharmacy. This type of pharmacy can offer you support, such as connect you with resources about your condition and work with you to figure out insurance issues. Ask your pharmacist to see if you need to get Elaprase (idursulfase) at a specialty pharmacy.
            Can Elaprase (idursulfase) cure Hunter syndrome?
            There's no cure for Hunter syndrome, but Elaprase (idursulfase) can help you or your child manage some of the symptoms. Talk with your provider to understand what other options there might be to help manage your condition.
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            What are the risks and warnings for Elaprase (idursulfase)?

            Elaprase (idursulfase) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Serious allergic reactions

            • Risk factors: People ages 7 years and younger who have certain types of genetic mutations (damage)

              Get medical attention right away if you experience symptoms such as trouble breathing, swelling of the face, throat or tongue, wheezing, hives, rash, flushing, or vomiting. Elaprase (idursulfase) can cause serious allergic reactions during and up to 24 hours after the IV infusion. Rarely, these reactions can even happen after you’ve safely received Elaprase (idursulfase) infusions in the past. If you ever had any prior allergic reaction to Elaprase (idursulfase), let your provider know so that they can give you treatments, such as inhalers, corticosteroids, and antihistamines during or after future Elaprase (idursulfase) infusions.

              Some people can develop antibodies, proteins that attack unfamiliar chemicals in the body, against Elaprase (idursulfase). This means that the medication won't work as well, because your body thinks it's a harmful substance and attacks it. This is most likely to occur in people with certain genetic mutations. Talk with your provider if you think this medication isn’t working for you.

              risk-warning

              Breathing problems caused by serious allergic reactions

              • Risk factors: Lung infection | Breathing problems

                Elaprase (idursulfase) can cause an allergic reaction that lowers your ability to breath. If you have breathing problems or an infection in your lungs, you're more at risk for not being able to recover from a severe allergic reaction that affects your breathing. This can lead to serious problems such as seizures or passing out. Your provider might suggest rescheduling your dose if you're experiencing short-term breathing problems due to an infection.

                risk-warning

                Heart problems caused by serious allergic reactions

                • Risk factors: Too much fluid

                  Elaprase (idursulfase) can make heart problems worse, especially if you're already at risk of having too much fluid in your body. If you have heart problems, you might need to be observed by your provider for a longer period of time after your infusion to make sure you don't have any serious side effects from it.

                  dosage

                  Elaprase (idursulfase) dosage forms

                  Typical dosing for Elaprase (idursulfase)

                  Elaprase (idursulfase) is only available as an IV infusion that’s given by a healthcare provider. The dose of this medication depends on your weight.

                  In general, the dosing of Elaprase (idursulfase) is 0.5 mg/kg given weekly as an IV infusion.

                  interactions

                  Interactions between Elaprase (idursulfase) and other drugs

                  Elaprase (idursulfase) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Elaprase (idursulfase). Please note that only the generic name of each medication is listed below.

                  Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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